DrugDashboards

Levalbuterol

Levalbuterol Hydrochloride · LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL · Solution · Respiratory (Inhalation) · Burel Pharmaceuticals, LLC

NDC 35573-0444-25 · 25 POUCH in 1 CARTON / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble. The price has held steady around $0.2411 per mL over the past year. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$0.2411per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicare Part B pays (ASP+6%)$0.0750per billing unit (0.5 MG)HCPCS J7614 · Jul 1, 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00115-9931-78) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$0.3672per unit
middle half $0.2850$0.5324 · 3,143 plans · Apr 1, 2026
Est. net of rebates
≈ $0.3672
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
57%of plans cover it
tier 4 · prior auth 100% · step therapy 0% · qty limit 14%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 6 quarters since 2024.

NADAC price per unit

$0$0.2$0.4Sep 2021Sep 2026$0.2411
61 price points · per MLSource: CMS NADAC

Medicare Part B (ASP)

Payment limit per 0.5 MG
$0.075
HCPCS J7614 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$422,820
8,008 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for levalbuterol hydrochloride (other) in the next 90 days

sole-source market · price up 4% YoY

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Regulatory

Application
ANDA203653
TE code
AN
Approval date
Mar 22, 2016
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Levalbuterol Hydrochloride (Solution)

LabelerStrengthFirst seenLast seen
Redpharm DrugLEVALBUTEROL HYDROCHLORIDE .63 mg/3mLJul 22, 2026Sep 3, 2026
A-S Medication SolutionsLEVALBUTEROL HYDROCHLORIDE .63 mg/3mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLEVALBUTEROL HYDROCHLORIDE .63 mg/3mLJul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCLEVALBUTEROL HYDROCHLORIDE .31 mg/3mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackLEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackLEVALBUTEROL HYDROCHLORIDE .63 mg/3mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackLEVALBUTEROL HYDROCHLORIDE .31 mg/3mLJul 15, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCLEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mLJul 15, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCLEVALBUTEROL HYDROCHLORIDE .63 mg/3mLJul 15, 2026Sep 2, 2026
Burel Pharmaceuticals, LLCLEVALBUTEROL HYDROCHLORIDE .31 mg/3mLJul 15, 2026Sep 2, 2026
Ritedose Pharmaceuticals, LLCLEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mLJul 15, 2026Sep 2, 2026
Ritedose Pharmaceuticals, LLCLEVALBUTEROL HYDROCHLORIDE .63 mg/3mLJul 15, 2026Sep 2, 2026
Ritedose Pharmaceuticals, LLCLEVALBUTEROL HYDROCHLORIDE .31 mg/3mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Levalbuterol — NDC 35573-0444-25," retrieved September 3, 2026, https://drugdashboards.com/drug/35573044425.

Free to cite with attribution — see how the data is put together.